Capecitabine and Vinorelbine in Treating Older Women Who Have Metastatic Breast Cancer With or Without Bone Involvement

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine and vinorelbine and to see how well they work in treating older women with metastatic breast cancer with or without bone involvement.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swiss Group for Clinical Cancer Research
• Treatments: Capecitabine; Vinblastine; Vinorelbine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically proven adenocarcinoma of the breast

• Phase I: Measurable or evaluable disease

• Phase II: Bidimensionally measurable disease

• No CNS metastases

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 65 and over

Sex:

• Female

Menopausal status:

• Postmenopausal

Performance status:

• ECOG/SAKK 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Normal peripheral blood counts

Hepatic:

• AST no greater than 2 times upper limit of normal (ULN) (no greater than 3 times ULN if liver metastases present)

Renal:

• Creatinine no greater than 1.5 times ULN

Other:

• No other prior or concurrent malignancy except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix

• No peripheral neuropathy grade 2 or higher

• No cognitive impairment or severe psychiatric disorder

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• More than 6 months since prior adjuvant chemotherapy

• No prior chemotherapy for metastatic or locally advanced disease

• No other concurrent chemotherapy

Endocrine therapy:

• Prior hormonal therapy for metastatic disease allowed

• No continuous concurrent steroids

• No concurrent systemic endocrine therapy for breast cancer

• No other concurrent endocrine therapy

Radiotherapy:

• No concurrent radiotherapy involving greater than 30% of bone marrow or mucosa

• Radiotherapy to nonindicator lesion allowed

Surgery:

• Not specified

Other:

• Bisphosphonates allowed if indicator lesion in nonbone site